Oral muscle training

ABSTRACT

A trans mucosal neuromuscular electrical stimulation device (1) including a mouthpiece (3, 103) and electrodes (32a, 33a, 132a, 133a) associated with the mouthpiece (3, 103). The device (1) and/or mouthpiece (3, 103) incorporates electrical circuitry operatively connecting the electrodes (32a, 33a, 132a, 133a) to a power source and is configured to provide, in use, electrical stimulation to one or more palate and/or tongue muscles via the electrodes (32a, 33a, 132a, 133a) through the oral mucosa. The treatment regime, including the location of stimulation and the parameters used, is designed to increase resting muscle tone and/or muscle tone during sleep.

This invention relates generally to oral muscle training, particularlyto oral muscle training devices, methods, systems and control software.More specifically, although not exclusively, this invention relates tothe training of muscles in the mouth for the treatment of sleepdisordered breathing.

Snoring and sleep apnoea are considered as part of a range of conditionsoften termed as sleep disordered breathing (SDB), with symptoms relatingto disordered breathing patterns during sleep. SDBs are not only anuisance, but they can also result in health problems, for examplefrequent waking from sleep, light sleeping, strain on the heart, lowoxygen levels in the blood, headaches and fatigue.

The breathing passage of humans between the back of the nose and mouth,to the level of the larynx, is a collapsible tube. It has been observedthat collapse of the breathing passage occurs at a positive airwaypressure in individuals who snore and/or suffer from sleep apnoeasyndrome and at a negative airway pressure in individuals who do not.

In an effort to address this phenomenon, treatments have been developedwhich include using a continuous positive airway pressure device to keepthe breathing passage open or wearing a mandibular advancement device tohold the jaw and tongue forward in order to increase the space at theback of the throat.

These devices can cause discomfort, they address the symptoms onlytemporarily, rather than addressing the underlying cause, and they mustbe used during sleep on an ongoing basis. As a result, users find itdifficult to fall asleep and compliance is therefore low. It wouldtherefore be desirable to provide a treatment that does not require theregular use of such devices during sleep and that addresses theunderlying cause for the condition.

Recent research studies have shown that implanting electrical nervestimulators into the tongue and diaphragm are effective in the treatmentof obstructive sleep apnoea. This involves intrusive surgery to implantsensors and electrodes on nerves in these areas. The device identifiesan episode of obstruction using the sensors and stimulates the tonguenerve to cause contraction to relieve the obstructive event. As withpacemakers, this approach leads to maintenance and other complications,such as battery replacement, risks associated with electrical fields andissues related to external security detection devices. In addition,stimulation only occurs during an obstructive episode during sleep; itdoes not address the underlying cause of the condition.

It is therefore a first non-exclusive object of the invention to providea treatment system, preferably to be used in an awake state, thatprovides a sustainable reduction in disordered breathing patterns duringsleep. It is a further, more general object of the invention to providea treatment system and device that is more effective in at least onerespect than existing systems and devices for the treatment of SDBs.

Accordingly, a first aspect of the invention provides an electricalstimulation device for training one or more oral muscles, for example atrans mucosal neuromuscular electrical stimulation device, the devicecomprising a mouthpiece, electrode means associated with the mouthpieceand electrical circuitry operatively connected to the electrode means,wherein the device or electrical circuitry is configured to provide, inuse, via the electrode means electrical stimulation to one or more oralmuscles, e.g. tongue muscle and/or palate muscles, through the lining ofthe mouth, for example the oral mucosa, e.g. to increase resting muscletone and/or muscle tone during sleep.

When a person is awake, the collapsible segment of the breathing passageis kept open due to the tone of the muscles that control this area. Whena person is asleep, this muscle tone reduces significantly. Evidence hasshown that this reduction of muscle tone is significantly greater inpatients who suffer from obstructive sleep apnoea, less so in those whosnore and notably less in individuals who suffer from neither of thesedisorders.

Research has demonstrated that increasing the pharyngeal muscle activityor tone reduces the collapsibility of the airway and the presentinvention is based on the realisation that electrical stimulation,particularly neuromuscular electrical stimulation, can be used tostimulate the muscles of the tongue and/or palate and/or the sensorynerves to improve muscle power and tone recovery.

The device or electrical circuitry is preferably configured to provide acurrent, for example an electric current or impulse current, such as abiphasic electric current or impulse current.

Another aspect of the invention provides an electrical stimulationdevice for training one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation device, the devicecomprising a mouthpiece, electrode means associated with the mouthpieceand electrical circuitry operatively connected to the electrode means,wherein the device or electrical circuitry is configured to provide, inuse, via the electrode means a biphasic electric current, for examplebiphasic electric impulse current.

By providing a biphasic electric current, particularly a biphasicelectric impulse current, tongue and/or palate muscles contributing tothe collapsibility of the airway can be stimulated along with thesensory nerves to increase resting muscle tone and muscle tone duringsleep.

The current is preferably a biphasic symmetrical current, but it mayadditionally or alternatively be a biphasic asymmetrical current thatmay either be balanced or unbalanced. The device or electrical circuitrymay be configured to provide, in use, via the electrode means anelectric current with a frequency of between 5 and 150 Hz.

Another aspect of the invention provides an electrical stimulationdevice for training one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation device, the devicecomprising a mouthpiece, electrode means associated with the mouthpieceand electrical circuitry operatively connected to the electrode means,wherein the device or electrical circuitry is configured to provide, inuse, via the electrode means an electric current with a frequency ofbetween 5 and 150 Hz.

The electric current may comprise a frequency of between 10 and 140 Hz,for example between 15 and 130 Hz, preferably between 20 and 120 Hz.Preferably, the electric current comprises a frequency of between 20 and50 Hz and/or between 50 and 120 Hz.

The device or electrical circuitry may be configured to provide two ormore currents, for example a first current and/or a second current,which second current may be different from and/or configurable orsettable independently from the first current. At least one, e.g. both,of the first and/or second current may comprise a biphasic current, eachof which is preferably symmetrical, but may be asymmetrical and eitherbalanced or unbalanced. At least one of the first and/or second currentmay comprise a frequency of between 5 and 150 Hz, for example between 10and 140 Hz, e.g. between 15 and 130 Hz, preferably between 20 and 120Hz. In some embodiments, one or the currents may comprise a frequency ofbetween 20 and 50 Hz and/or the other current may comprise a frequencyof between 50 and 120 Hz.

The inventors believe that the application of an electric current in oneor each of these two frequency ranges is particularly suited totargeting palate and tongue muscles contributing to the collapsibilityof the airway.

The device or electrical circuitry may be configured to provide, in use,the or at least one or each electrical current to one or more oralmuscles, such as palate and/or tongue muscles, for example through thelining of the mouth, e.g. the oral mucosa, such as to increase restingmuscle tone and/or muscle tone during sleep. In some embodiments, thedevice is configured to provide, in use, the electrical current, e.g.the first electrical current, to one or more palate muscles.Additionally or alternatively, the device may be configured to provide,in use, the electrical current, e.g. the second electrical current, toone or more tongue muscles, e.g. via the dorsal tongue surface.Additionally or alternatively, the device may be configured to provide,in use, the electrical current, e.g. the first or second electricalcurrent, to one or more tongue muscles via the underside of the tongue.

In embodiments, the mouthpiece may comprise one or more arms and/or oneor more appendages or flanges which may extend from the one or morearms, e.g. for contacting one or more oral muscles. At least one armand/or at least one appendage or flange may be flat or planar, forexample with major surfaces. Optionally, the mouthpiece may comprise apair of arms each of which may comprise one or more appendages orflanges. In some embodiments, the mouthpiece comprise a pair of armsthat may extend at least partially alongside each other and/or at anangle relative to one another and/or parallel to each other. Forexample, the mouthpiece may comprise a pair of arms joined together atone end and diverging from one another, for example in a substantiallyV-shape or U-shape or horseshoe shape.

The one or more appendages or flanges may extend inwardly of the pair ofarms, e.g. from one arm and toward the other arm. In some embodiments,each arm comprises at least one appendage or flange, for exampleopposite one another and/or extending toward one another. Inembodiments, each arm comprises two or more appendages or flanges, forexample an appendage or flange extending from a free end of each armand/or an appendage or flange extending from an intermediate portion ofeach arm.

At least one appendage or flange may be curved, e.g. a flat curved shapeor member, and/or extend upwardly or downwardly or out of the plane ofthe mouthpiece or at least one arm thereof. At least one appendage orflange may be shaped to cooperate or approximate or accommodate a tonguesurface, for example a dorsal tongue surface or a sublingual tonguesurface. In embodiments, the mouthpiece comprises at least one appendageor flange that is shaped to cooperate or approximate or accommodate adorsal tongue surface and at least one appendage or flange that isshaped to cooperate or approximate or accommodate a sublingual tonguesurface. In embodiments having a pair of arms, each arm may comprise anappendage or flange shaped to cooperate or approximate or accommodate adorsal tongue surface and an appendage or flange that is shaped tocooperate or approximate or accommodate a sublingual tongue surface.

At least one of the appendages or flanges may comprise one or moreelectrodes or series thereof. At least one electrode or series ofelectrodes may be adjacent and/or associated with and/or exposed at asurface, e.g. a major surface, of the at least one appendage or flange.In embodiments, at least one of the appendages or flanges compriseselectrodes associated with each of its major surfaces. The electrodesassociated with one of the major surfaces may be isolated and/orcontrollable independently from another or the other major surfacethereof. Additionally or alternatively, the electrodes of or associatedwith one appendage or flange may be isolated and/or controllableindependently from at least one other appendage or flange.

In embodiments, the mouthpiece may comprise a pair of arms joinedtogether at one end and diverging from one another to provide asubstantially horseshoe shape with one or more flanges extendinginwardly from at least one arm, the or each flange comprising electrodemeans. The mouthpiece may comprise a pair of flanges each extendinginwardly from a respective arm, which flanges are shaped to accommodatea dorsal tongue surface. The mouthpiece may comprises a pair of flangeseach extending inwardly from a respective arm, which flanges are shapedto accommodate a sublingual tongue surface. Each of the pair of flangesmay be shaped to accommodate a dorsal tongue surface extends from at oradjacent a free end of the arm and/or each of the pair of flanges may beshaped to accommodate a sublingual tongue surface extends from anintermediate portion of the arm.

Another aspect of the invention provides an electrical stimulationdevice for training one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation device, the devicecomprising a mouthpiece, electrode means associated with the mouthpieceand electrical circuitry operatively connected to the electrode means,wherein the mouthpiece comprises a pair of arms joined together at oneend and diverging from one another with one or more flanges extendinginwardly from at least one arm, the or each flange including at leastpart of the electrode means associated therewith for providingelectrical stimulation to one or more oral muscles.

Yet another aspect of the invention provides an electrical stimulationmouthpiece for training one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation mouthpiece, the mouthpiececomprising a pair of arms joined together at one end and diverging fromone another with one or more flanges extending inwardly from at leastone arm, wherein the or each flange includes electrode means associatedtherewith for providing electrical stimulation to one or more oralmuscles.

The mouthpiece may comprise a gripping base, which may comprise anenlarged end, e.g. an enlarged free end, which may be connected orsecured to, e.g. formed integrally with, the mouthpiece or a body or oneor more or each arm thereof, for example by a necked portion.

The electrode means preferably comprises at least one anode and at leastone cathode, for example two or more anodes and/or two or more cathodes,e.g. a plurality of anodes and a plurality of cathodes. At least part ofthe electrode means, for example one or more or each or all of theelectrodes, may be mounted to or on or within and/or at least partiallyhoused or contained within the mouthpiece. In some embodiments, themouthpiece comprises a shield or shield means, for example on one sideof the electrode means, e.g. for inhibiting or preventing the electricalstimulation or current from being applied or provided by or at or fromone side of the mouthpiece. Suitable materials for the shield or shieldmeans will be apparent to those skilled in the art.

In embodiments, the electrode means is configured or operable to provideor apply, e.g. selectively, the electrical stimulation or current at orfrom at least one or each or both sides, for example by including the ora shielding means or shield between a first set or series of electrodemeans or electrodes and a second set or series of electrode means orelectrodes. In some embodiments, the first electrical current isprovided or applied at or from a first side, e.g. major side, of themouthpiece and/or by the first set or series of electrode means orelectrodes. Additionally or alternatively, the second electrical currentmay be provided or applied at or from a second side, e.g. major side, ofthe mouthpiece and/or by the second set or series of electrode means orelectrodes. In other embodiments, the first and second electricalcurrents may be provided or applied from at least one or each or bothsides.

The mouthpiece may be insertable into the mouth and held in place, e.g.manually. The mouthpiece may be at least partially flattened and/orsubstantially flat and/or paddle-shaped, for example with at least oneflat and/or major surface, preferably two flat major surfaces. In someembodiments, the device may include a handle to which the mouthpiece maybe connected or mounted or attached, for example rigidly and/orreleasably, e.g. to enable the mouthpiece to be inserted and/or held, inuse, within one or more locations or positions and/or orientationswithin the mouth. In some embodiments, the mouthpiece is free of anymounting means for mounting or securing it to or in or within the mouthof a user.

In embodiments, the mouthpiece may include a mounting means. Themounting means may be for mounting the mouthpiece to an upper part orportion of the mouth, for example such that the mouthpiece or the or afirst side or surface thereof is or may be in contact with and/oradjacent one or more palate muscles and/or the roof of the mouth and/orthe mouthpiece or the or a second side or surface thereof is or may bein contact with and/or adjacent one or more tongue muscles, for examplea dorsal tongue surface. Additionally or alternatively, the mountingmeans may be for mounting the mouthpiece to a lower part or portion ofthe mouth, for example such that the mouthpiece or the or a first sideor surface thereof is or may be in contact with and/or adjacent one ormore tongue muscles, for example a sublingual tongue surface. Inembodiments, the device comprises a first mouthpiece with mounting meansfor mounting it to an upper part or portion of the mouth and a secondmouthpiece for mounting it to a lower part or portion of the mouth.

The device or handle may comprise an input means or activator, which mayinclude one or more input devices, buttons and/or push buttons and/orswitches and/or dials or the like, e.g. for enabling or activating orinitiating the electrical stimulation or current. The device or handlemay comprise a power source and/or a cable connectable to a powersource. In some embodiments, the device comprises a main body thatincludes or incorporates or provides the handle and/or which includes orhouses the power source, which may comprise a rechargeable power sourceor one or more batteries that may be rechargeable, and/or which caneither include the cable or be operatively, e.g. inductively,connectable to a charging station that includes or incorporates thecable, for example to enable the power source to be recharged. Thedevice may include the charging station.

In some embodiments, the device comprises an adjustment means oradjuster, e.g. a frequency adjustment means or adjuster, for adjustingthe frequency of the current or of the first and/or second currents, forexample a respective first and second current frequency adjustment meansor adjuster for adjusting the frequency of the current, e.g. between oneof the aforementioned ranges. In embodiments, the adjustment means oradjuster is a step-wise adjustment means or adjuster and/or isconfigured to enable a user to select from one of two or more, e.g.three, four or five, predetermined frequency settings. The device may beoperable or configured to provide the first and second currentssimultaneously and/or concurrently and/or in parallel. Additionally oralternatively, the device may be operable or configured to provide thefirst and second currents in series and/or in sequence and/or insuccession.

The current or at least one, e.g. both, of the first and/or secondcurrent may comprise an impulse current. The pulse duration of the oreach impulse current may be between 50 and 1000 μs, for example between100 and 900 μs, e.g. between 150 and 800 μs, preferably between 200 and700 μs. Preferably, the or a further adjustment means or adjuster, e.g.an pulse duration adjustment means or adjuster, of the device isprovided for adjusting the pulse duration, for example between one ofthe aforementioned ranges.

The electrical stimulation or current or first and/or second currentsmay comprise an intensity or current amplitude, which is preferablyselected or selectable to provide maximum contraction of the musclesbeing treated. By way of example, the intensity or amplitude maycomprise approximately 10 mA, for example between 1 and 100 mA, such asbetween 5 and 50 mA, for example between 5 and 15 mA or between 7 and 25mA, e.g. between 8 and 12 mA. The or a further adjustment means oradjuster, e.g. an intensity or amplitude adjustment means or adjuster,may be provided for adjusting the intensity or amplitude, for examplefrom 0 to 500 mA or from 0 to 250 mA or from 0 to 200 mA or from 0 to150 mA or from 0 to 100 mA.

In some embodiments, the device is configured or programmed to providethe electrical stimulation or electric current or the first and/orsecond electric current for a predetermined period, which may comprisebetween 1 minute and 1 hour, for example between 5 and 30 minutes,preferably between 10 and 20 minutes. The or a further adjustment meansor adjuster, e.g. a treatment duration adjustment means or adjuster, maybe provided for adjusting the treatment duration, for example from 0 to10 hours or from 0 to 5 hours or from 0 to 1 hour or from 0 to 30minutes.

The device may comprise a control means, which may be programmed orprogrammable, for example to control one or more features of theelectrical stimulation or current or currents, for example according toa predetermined treatment regime. The control means may comprise acontrol system and/or a controller and/or may comprise or be at leastpartially comprised in the electrical circuitry. The control means maycomprise at least part of the adjustment means or adjuster, e.g. one ormore of the frequency and/or pulse duration and/or intensity and/oramplitude and/or treatment duration adjustment means or adjusters.

In some embodiments, the input means may be for or configured oroperable to control and/or adjust one or more features of the electricalstimulation or electric current or the first and/or second electriccurrent, for example the frequency and/or pulse duration and/orintensity and/or amplitude and/or treatment duration. Additionally oralternatively the device or input means may comprise an interface orconnection means such as a connector or receptacle for connecting thedevice or control means to another device, such as a personal computeror a handheld device, which may be operable to program and/or controland/or adjust one or more of the aforementioned features.

The device or control means or adjustment means may be configured orprogrammed to control one or more features of the electrical stimulationor electric current or the first and/or second electric current, forexample in a predetermined manner and/or according to a predeterminedtreatment regime. The device or control means may be operable orprogrammable to create and/or alter the predetermined treatment regime,for example by a device to which the electrical stimulation device isconnected, e.g. via the input means.

Another aspect of the invention provides a computer program elementcomprising computer readable program code means for causing a processorto execute a procedure to implement a method or treatment regimecomprising providing electrical stimulation to one or more oral muscles,e.g. palate and/or tongue muscles, through the lining of the mouth, forexample the oral mucosa, e.g. to increase resting muscle tone and/ormuscle tone during sleep.

Another aspect of the invention provides a method or treatment regime,e.g. for training one or more oral muscles such as by trans mucosalneuromuscular electrical stimulation, the method comprising providing orapplying electrical stimulation to one or more oral muscles, e.g. palateand/or tongue muscles, through the lining of the mouth, for example theoral mucosa, e.g. to increase resting muscle tone and/or muscle toneduring sleep.

For the avoidance of doubt, any of the features described herein applyequally to any aspect of the invention.

The method or treatment regime may comprise providing or applying acurrent, for example an electric current or impulse current, such as abiphasic electric current or impulse current, e.g. to the one or moreoral muscles.

Another aspect of the invention provides a method or treatment regime,e.g. for training one or more oral muscles such as by trans mucosalneuromuscular electrical stimulation, the method comprising providing orapplying, e.g. via electrode means, a biphasic electric current, forexample biphasic electric impulse current, to one or more oral muscles,e.g. palate and/or tongue muscles, through the lining of the mouth, forexample the oral mucosa.

The method or treatment regime may comprise providing or applying afirst current and/or a second current, which second current may bedifferent from the first current. The current or at least one, e.g.both, of the first and/or second current may comprise an alternatingcurrent. The or at least one of the or each current may comprise afrequency of between 5 and 150 Hz, for example between 10 and 140 Hz,e.g. between 15 and 130 Hz, preferably between 20 and 120 Hz, morepreferably between 20 and 50 Hz and/or between 50 and 120 Hz. In someembodiments, the first current comprises a frequency of between 20 and50 Hz and/or the second current comprises a frequency of between 50 and120 Hz.

In embodiments, phases of the biphasic current, or the first and secondcurrents, may be applied simultaneously and/or concurrently. In someembodiments, phases of the biphasic current, or the first and secondcurrents, may be applied in series and/or in sequence and/or insuccession.

The current or at least one, e.g. both, of the first and/or secondcurrent may comprise an impulse current. The pulse duration of the oreach impulse current may be between 50 and 1000 μs, for example between100 and 900 μs, e.g. between 150 and 800 μs, preferably between 200 and700 μs.

The electrical stimulation or current or first and/or second currentsmay comprise an intensity or current amplitude, which is preferablyselected or selectable to provide maximum contraction of the musclesbeing treated. By way of example, the intensity or amplitude maycomprise approximately 10 mA, for example between 1 and 100 mA, such asbetween 5 and 50 mA, for example between 5 and 15 mA or between 7 and 25mA, e.g. between 8 and 12 mA.

The method or treatment regime may comprise providing or applying theelectrical stimulation or electric current or the first and/or secondelectric current for a predetermined period, which may comprise between1 minute and 1 hour, for example between 5 and 30 minutes, preferablybetween 10 and 20 minutes.

In some embodiments, the method or treatment regime may compriseproviding or applying the electrical stimulation or electric current orthe first and/or second electric current for a first predeterminedperiod to a first muscle or group of muscles and/or to an upper ordorsal surface of the tongue. The first muscle or group of muscles mayinclude one or more palate and/or tongue muscles, e.g. one or more ofthe intrinsic surface muscles, the uvular muscle, the levator velipalatini muscle and the palatopharyngeus muscle.

Additionally or alternatively, the method or treatment regime maycomprise providing or applying the electrical stimulation or electriccurrent or the first and/or second electric current for a secondpredetermined period to a second muscle or group of muscles and/or tothe underside of the tongue, e.g. sublingually. The second muscle orgroup of muscles may include one or more palate and/or tongue muscles,one or more of which may be different from the first muscle or group ofmuscles e.g. the genioglossus muscle. By way of example, the firstpredetermined period may comprise between five and thirty minutes, forexample five or ten or fifteen or twenty or thirty minutes and/or thesecond predetermined period may comprise between five and thirtyminutes, for example five or ten or fifteen or twenty or thirty minutes.

Additionally or alternatively, the method or treatment regime comprisescarrying out one or more of the aforementioned steps at predeterminedintervals, which may comprise between one and ten times per day or anynumber therebetween, for example twice per day. Additionally oralternatively, the method or treatment regime comprises carrying out oneor more of the aforementioned steps over a predetermined treatmentperiod, which may comprise between one and twelve weeks, for examplebetween two and ten weeks, e.g. between five and eight weeks, such assix weeks.

The method or treatment regime may comprise adjusting one or morefeatures of the electrical stimulation or electric current or the firstand/or second electric current, for example the frequency and/or pulseduration and/or intensity and/or amplitude and/or treatment duration.The adjustment may be carried out using an input means, such as one ormore push buttons and/or dials or the like or via an interface orconnection means such as a connector or receptacle by a device, such asa personal computer or a handheld device.

In some embodiments, the method or treatment regime comprises a first,e.g. treatment, period, for example during which the electricalstimulation or electric current or the first and/or second electriccurrent is or are provided or applied, e.g. to build resting muscle toneand/or muscle tone during sleep. The method or treatment regime may alsocomprise a second, e.g. maintenance, period, for example during whichone or more features of the electrical stimulation or electric currentor the first and/or second electric current is adjusted or changed, e.g.with respect to the first period, e.g. to maintain resting muscle toneand/or muscle tone during sleep. The first period may comprise a firstregime and/or the second period may comprise a second regime, e.g.different from the first regime.

In an exemplary embodiment, the method or treatment regime comprisesproviding or applying electrical stimulation to the one or more oralmuscles for 10 to 20 minutes, twice per day for six weeks, for exampleto build resting muscle tone and/or muscle tone during sleep.Additionally or alternatively, the method or treatment regime maycomprise providing or applying electrical stimulation to the one or moreoral muscles for 10 to 20 minutes, once per day on an ongoing basis, forexample to maintain resting muscle tone and/or muscle tone during sleep.

Another aspect of the invention provides a method or treatment regime,e.g. for training one or more oral muscles such as by sensorystimulation, the method comprising providing or applying a vibratorystimulation to one or more oral muscles, e.g. palate and/or tonguemuscles. The method may further comprise any one or more features of themethod described above.

A further aspect of the invention provides a computer program elementcomprising computer readable program code means for causing a processorto execute a procedure to implement the aforementioned method ortreatment regime. A yet further aspect of the invention provides thecomputer program element embodied on a computer readable medium.

A yet further aspect of the invention provides a computer readablemedium having a program stored thereon, where the program is arranged tomake a computer execute a procedure to implement the aforementionedmethod or treatment regime.

A yet further aspect of the invention provides a control means orcontrol system or controller comprising the aforementioned computerprogram element or computer readable medium or for controlling atreatment regime to train one or more oral muscles, such as by transmucosal neuromuscular electrical stimulation, for example forcontrolling the method described above.

Within the scope of this application it is expressly envisaged that thevarious aspects, embodiments, examples and alternatives set out in thepreceding paragraphs, in the claims and/or in the following descriptionand drawings, and in particular the individual features thereof, may betaken independently or in any combination. Features described inconnection with one aspect or embodiment of the invention are applicableto all aspects or embodiments, unless such features are incompatible.

Embodiments of the invention will now be described by way of exampleonly with reference to the accompanying drawings in which:

FIG. 1 is a perspective view of an electrical stimulation deviceaccording to an embodiment of the invention;

FIG. 2 is a perspective view of the main body of the device of FIG. 1;

FIG. 3 is a perspective view of the mouthpiece of the device of FIG. 1;

FIG. 4 is a perspective view of the charging station of the device ofFIG. 1;

FIG. 5 is a schematic of a human mouth showing the palatoglossus andsurface of the tongue;

FIG. 6 is a schematic illustrating the extrinsic tongue muscles of ahuman tongue;

FIG. 7 is a schematic illustrating the intrinsic tongue muscles of ahuman tongue;

FIG. 8 is another schematic of a human mouth showing the muscles of thepalate;

FIG. 9 is a schematic illustrating further muscles of the palate;

FIG. 10 is a top view of the mouthpiece of an electrical stimulationdevice according to a second embodiment of the invention; and

FIG. 11 is a side view of the mouthpiece of FIG. 10.

Referring now to FIGS. 1 to 4, there is shown an electrical stimulationdevice 1 including a main body 2, a mouthpiece 3 and a charging station4. The main body 2 serves as a handle, is substantially cylindrical inthis embodiment and includes a first, upper end 20 with a male connector21 having a projection 22 on each of its side to provide a bayonetfitting and an electrical socket 23 for receiving an electricalconnector (not shown) of the mouthpiece 3. On its front surface, themain body 2 also includes an ON/OFF button 2 a, four dials 24, 25, 26,27, a USB port 28 and a second, lower end 29 with a receptacle (notshown) for receiving a projection 41 of the charging station 4.

The main body 2 also contains batteries (not shown) and electricalcircuitry including inverters for converting the direct current of thebatteries into two separate symmetrical biphasic currents. The firstdial 24 is operable to adjust the current amplitude of a first biphasiccurrent from 0 to 100 mA. The second dial 25 is operable to adjust thecurrent amplitude of a second biphasic current from 0 to 100 mA. Thethird dial 26 is operable to adjust the duration of the period duringwhich the first biphasic current is supplied from 1 to 30 minutes. Thefourth dial 27 is operable to adjust the duration of the period duringwhich the second biphasic current is supplied from 1 to 30 minutes.

The USB port 28 is configured to enable the device 1 to be connected toa personal computer (not shown) to program one or more characteristicsof the first and second biphasic currents independently. In thisembodiment, the frequency of the first biphasic current is set at avalue between 20 and 50 Hz, the second biphasic current is set at avalue between 50 and 120 Hz and the pulse duration of each biphasiccurrent is set at a value between 200 and 700 μs. The personal computer(not shown) may also incorporate control software operable to overridethe dials 24, 25, 26, 27. The software may be programmed to applybiphasic currents having predetermined characteristics independent fromone another, such as amplitudes, frequencies and pulse durations and fora predetermined period of time. It is further envisaged that the device1 could incorporate a memory on which is stored such predeterminedcharacteristics, which may be modified by connecting a personal computer(not shown) to the device 1 via the USB port 28. In such embodiments,the dials may be omitted or configured to adjust the aforementionedcharacteristics from their pre-programmed values. In some embodiments,it is envisaged that more or less functionality is provided by manualdials, buttons and the like.

The mouthpiece 3 includes a cylindrical base 30 and a substantiallyflat, paddle-shaped contact portion 31 formed integrally with an upperend of the base 30 and having first and second major surfaces 32, 33.The base 30 includes a receptacle (not shown) at its lower end 34 withan electrical connector (not shown) for receipt within the electricalsocket 23 of the main body 2. The mouthpiece 3 also includes electricalcircuitry (not shown) feeding a respective series of electrodes 32 a, 33a beneath each of the major surfaces 32, 33. The electrode series 32 a,33 a are electrically isolated from one another by a shielding material.The electrical circuitry (not shown) of the mouthpiece 3 is operativelyconnected, in use, to the electrical circuitry (not shown) of the mainbody 2 such that a first series of the electrodes 32 a delivers thefirst biphasic current and a second series of electrodes 33 a deliversthe second biphasic current.

In this embodiment, the mouthpiece 3 is provided as a separate componentfrom the main body 2 and is configured such that it may be easilycleaned between sessions. However, in alternative embodiments, themouthpiece 3 may be formed integrally with the main body 2. In yetfurther embodiments, the mouthpiece 3 may incorporate mounting means formounting it to an upper and/or lower part of a user's mouth in a similarmanner to a retainer. In such embodiments, the device 1 could include apair of mouthpieces 3 each incorporating a mounting means, wherein afirst mouthpiece 3 is adapted to be mounted to an upper part of theuser's mouth and a second mouthpiece 3 is adapted to be mounted to alower part of the user's mouth. The first mouthpiece 3 could incorporatetwo series of electrodes 32 a, 33 a to contact the roof of the user'smouth and stimulate one or more palate muscles on one side and tocontact the dorsal surface of the tongue and stimulate one or moretongue muscles on its other side. The second mouthpiece 3 couldincorporate a single series of electrodes 32 a to stimulate thesublingual muscles. The or each mouthpiece 3 may include the powersource and, for example, a wireless communication means, such as aBluetooth communication means, that communicates with the personalcomputer (not shown).

The charging station 4 has a cylindrical base 40 with a cylindricalprojection 41 and an electrical cable 42 for connecting the chargingstation 4 to a source of mains electricity. The projection 41 in thisembodiment incorporates an inductive coupling and the station 4 includeselectrical circuitry connected to the electrical mains cable 42 forsupplying electricity to the inductive coupling to inductively chargethe batteries (not shown) in the main body 2.

Turning now to FIGS. 5 to 9, there is shown various tongue and palatemuscles. Features of the mouth shown in FIGS. 5 to 7 illustrate moreclearly the tongue muscles, wherein there is shown the pharyngopalatinearch 51, palatine tonsil 52, palatoglossus 53, buccinator 54, valatepapillae 55, fungiform papillae 56, dorsal tongue surface 57,styloglossus 58, hyoglossus 59, mandible bone 60, genioglossus 61,longitudinal, transverse and vertical intrinsic muscles 62, 63, 64 andgeniohydoid 65.

It is well established that the tone of the genioglossus muscle 61 mostaffects the collapsibility of the tongue as it is the biggest of theextrinsic muscle and responsible for pulling the tongue forward andincreasing the airway opening in the throat. The tone of intrinsicsurface muscles, such as the longitudinal and transverse intrinsicmuscles 62, 63, also contribute to the reduction of the collapsibilityof the airway.

Features of the mouth shown in FIGS. 8 and 9 illustrate more clearly thepalate muscles, wherein there is shown the dental arch 66, premaxilla67, incisive foramen 68, palatine process of maxilla 69, palatine bone70, posterior nasal spine 71, palatine foramen 72, hamulus 73, tensorpalatini muscle 74, levator veli palatini muscle 75, tensor velipalatini muscle 76, uvular muscle 77 and palatopharyngeus muscle 78.

To a varying degree, the constrictor and dilator muscles of the palatealso contribute to snoring and sleep apnoea. The aim of the treatment isto dilate the throat, hence electrical stimulation is directed at thedilatory palate muscles in the midline, such as the uvular muscle 77,the levator veli palatini muscle 75 and the palatopharyngeus muscle 78.

In use, the mouthpiece 3 is applied to the dorsal tongue surface 57 andthe aforementioned palate muscles and two biphasic currents are applied,each of which is configured with a first set of parameters includingintensity, frequency and pulse duration. These biphasic currents aretransmitted through the lining of the mouth, the oral mucosa, tostimulate the intrinsic surface muscles 62, 63, the uvular muscle 77,the levator veli palatini muscle 75 and the palatopharyngeus muscle 78.The parameters are selected to provide maximal contraction of thesemuscles in the user and the treatment is carried out for a period of 20minutes.

The intensity, frequency and pulse duration are then adjusted and themouthpiece 3 is applied to the underside of the tongue. The two biphasiccurrents, now having a second set of parameters, are applied andtransmitted trans mucosally to stimulate the genioglossus muscle 61. Thesecond set of parameters are selected to provide maximal contraction ofthe user's genioglossus muscle 61 and the treatment is carried out for aperiod of 20 minutes.

The application of biphasic currents according to the parametersdescribed above stimulate the aforementioned skeletal muscles. It isalso believed that the application of this biphasic current to theseskeletal muscles creates a further, sensory function, such as avibratory sensation. Whilst not wishing to be bound by any theory, it isbelieved that this electrical and vibratory stimulation of the nervesprovides feed back to the brain which further enhances the improvementin muscle tone. Specifically, it is believed that the effectiveness ofthis treatment is enhanced by multisensory integration within thenervous system.

By way of example, a treatment regime could involve a six week inductionperiod during which each of the aforementioned muscle groups arestimulated for a period of 10 to 20 minutes, twice daily. The treatmentregime, which is designed to build muscle tone, could then be followedby an ongoing maintenance regime involving 10 to 20 minute sessions onceper day.

Referring now to FIGS. 10 and 11, there is shown a mouthpiece 103according to a second embodiment similar to the first embodiment,wherein like references depict like features with a prefix 1. Themouthpiece 103 according to this embodiment includes a gripping base 130and a pair of curved arms 131 formed integrally with one end of the base130 to form a horseshoe shape. Each of the arms has first and secondcontact flanges 132, 133 within which is embedded electrodes (notshown).

The first contact flanges 132 extend inwardly toward one another fromthe free end of a respective one of the arms 131 and upwardly to form acurved shape for accommodating the dorsal tongue surface 57 of a tongueof a patient (not shown). The second contact flanges 133 extend inwardlytoward one another from an intermediate part of a respective one of thearms 131 and downwardly to form a curved shape for accommodating thesublingual tongue surface.

The base 130 includes an enlarged end 134 joined to the arms 131 by anecked portion 135. The end surface of the enlarged end 134 includes anelectrical connector 136 for connection with a source of power (notshown). The connector 136 may comprise a USB, microUSB or any othersuitable type of wired connector. In other embodiments, the connector isreplaced with a wireless connection means. In some embodiments, themouthpiece incorporates a power source, such as a battery.

Similar to the first embodiment, the mouthpiece 103 also includeselectrical circuitry (not shown) feeding a respective series ofelectrodes 132 a, 133 a at each surface of each flange 132, 133, that isto say each of the upper and lower surfaces of each of the flanges 132,133. Each of these electrode series 132 a, 133 a is electricallyisolated from the others by a shielding material, thereby enabling allsurrounding muscles to be stimulated simultaneously or in any sequencerequired. The electrodes 132 a, 133 a cooperate with the outer surfaceof the flanges 132, 133 with which they are associated to form asubstantially contiguous surface. In this embodiment, the mouthpiece 103is formed of a silicon grade or a biocompatible grade plastic material.The electrodes 132 a, 133 a in this embodiment are preferably formed ofgold or copper or composite material or any such alloy with an exposedsurface.

In use, the mouthpiece 103 is placed in a patient's mouth and the tongueof the patient is received within the mouthpiece 103 such that thedorsal tongue surface 57 is in contact with the first contact flanges132 and the sublingual tongue surface is in contact with the secondcontact flanges 133. It will be appreciated by those skilled in the artthat the first flanges 132 will contact a rearward portion of the dorsaltongue surface 57 and the second flanges 133 will contact a frontwardportion of the sublingual tongue surface. With the patient's mouthclosed, the flanges 132, 133 are also able to contact and stimulateadjacent muscles on the other side of the tongue, for example the palatemuscles. The muscles are stimulated in a similar manner to the device 1according to the first embodiment, but this mouthpiece 103 enables themuscles to be stimulated on both sides of the tongue simultaneously. Itwill be appreciated that with this design, the muscles based in andaround the tongue may be stimulated, including those in hard and softpalate areas.

It will be appreciated by those skilled in the art that severalvariations to the aforementioned embodiments are envisaged withoutdeparting from the scope of the invention. For example, the mouthpiece 3may take any suitable form, but is preferably designed to enable theelectrical stimulation to be applied to the appropriate muscles asdescribed above. The dials 24, 25, 26, 27 may be replaced with othersimilar adjustment means or even omitted as explained above. Themouthpiece 3 and main body 2 may be provided as an integral unit and thecharging station 4 may be omitted, for example the main body 2 mayincorporate a mains cable 42 or simply require single use batteries orsome other power source. Similarly, the USB port 28 may be omitted orreplaced with some other connection means, which may be a wirelessconnection means. It will also be appreciated by those skilled in theart that any number of combinations of the aforementioned featuresand/or those shown in the appended drawings provide clear advantagesover the prior art and are therefore within the scope of the inventiondescribed herein.

The invention claimed is:
 1. A trans mucosal neuromuscular electricalstimulation device comprising a mouthpiece, at least one electrodeassociated with the mouthpiece and electrical circuitry operativelyconnected to the electrode, wherein the mouthpiece comprises a memberconfigured to bear against, in use, the dorsal surface of a tongue toenable electrical stimulation to be provided from the electrode totongue muscles via the dorsal surface of the tongue and through the oralmucosa to increase resting muscle tone or muscle tone during sleep. 2.The device according to claim 1, wherein the mouthpiece comprises a pairof arms joined together at one end and diverging from one another, themember comprising a flange extending inwardly from one of the arms forbearing against the dorsal surface of the tongue.
 3. The deviceaccording to claim 2, wherein the mouthpiece comprises a further flangeextending inwardly from one of the arms, which further flange isconfigured to bear against, in use, a sublingual tongue surface.
 4. Thedevice according to claim 1, wherein the member comprises a pair offlanges each extending inwardly from a respective arm, which flanges areconfigured to bear against, in use, a respective dorsal tongue surface.5. The device according to claim 4, wherein the member comprises a pairof further flanges each extending inwardly from a respective arm, whichfurther flanges are shaped to accommodate a respective sublingual tonguesurface.
 6. The device according to claim 5, wherein each of the pair offlanges shaped to accommodate a respective dorsal tongue surface extendsfrom at or adjacent a free end of the respective arm and each of thepair of further flanges shaped to accommodate a respective sublingualtongue surface extends from an intermediate portion of the respectivearm.
 7. The device according to claim 5, wherein the pair of flangesconfigured to bear against, in use, the respective dorsal tongue surfacecomprise a first series of electrodes operable to provide a firstelectrical current and the pair of further flanges shaped to accommodatea respective sublingual tongue surface comprise a second series ofelectrodes operable to provide a second electrical current configurableor settable independently from the first current.
 8. The deviceaccording to claim 1, further comprising a controller programmed orprogrammable to control one or more features of the electricalstimulation according to a predetermined treatment regime.
 9. A transmucosal neuromuscular electrical stimulation device comprising amouthpiece which is free of a mounting retainer for securing themouthpiece to the teeth of a user and having a pair of arms, which armsare joined together at one end and diverge away from each other, aflange which extends from each arm, the mouthpiece being locatablewithin the mouth of a user such that each flange bears against asublingual surface of the tongue, each flange comprising at least oneelectrode and electrical circuitry operatively connected to eachelectrode, to enable electrical stimulation to be provided from theelectrode to tongue muscles via the sublingual surface of the tongue toincrease resting muscle tone or muscle tone during sleep.
 10. A deviceaccording to claim 9, wherein each arm comprises a further flange at oradjacent a distal portion of each arm, each further flange beingconfigured to bear against a dorsal surface of the tongue, in use.
 11. Adevice according to claim 10, wherein the mouthpiece is formed fromsilicone.
 12. A method treating sleep disordered breathing by trainingone or more oral muscles by trans mucosal neuromuscular electricalstimulation, the method comprising locating a mouthpiece within themouth of a patient, the mouthpiece having a pair of arms, which arms arejoined together at one end and diverge away from each other, a flangewhich extends from each arm to bear against a sublingual surface of thetongue and each flange comprising at least one electrode, applyingelectrical stimulation via the electrodes to tongue muscles via thesublingual surface of the tongue through the oral mucosa to increaseresting muscle tone or muscle tone during sleep.
 13. A method accordingto claim 12, wherein the method is conducted whilst the patient isawake.
 14. A method according to claim 12, the method comprisingapplying the electrical stimulation for a first period of from between 1minute and 1 hour.
 15. A method according to claim 12, comprisingapplying the electrical stimulation as a first electrical current andapplying a second electrical current.
 16. A method according to claim15, comprising applying the first electrical current to the dorsaltongue surface via a further flange extending from each of one of thearms of the mouthpiece and applying the second electrical currentsublingually.
 17. A method according to claim 15, comprising applyingthe first electrical current and the second electrical currentsimultaneously.
 18. A method according to claim 15, comprising applyingthe first electrical current and the second electrical current in seriesor in sequence or in succession.
 19. A method treating sleep disorderedbreathing by training one or more oral muscles by trans mucosalneuromuscular electrical stimulation, the method comprising locating amouthpiece within the mouth of a patient, the mouthpiece having a pairof arms, which arms are joined together at one end and diverge away fromeach other, a flange which extends from each arm to bear against adorsal surface of the tongue and each flange comprising at least oneelectrode, applying electrical stimulation via the electrodes to tonguemuscles via the dorsal surface of the tongue through the oral mucosa toincrease resting muscle tone or muscle tone during sleep.
 20. A methodaccording to claim 19, wherein the method is conducted whilst thepatient is awake.